Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00211237
Status:
COMPLETED
Last Update Posted:
2021-01-05
First Post:
2005-09-13
Brief Title:
CAFE Study - Cancer Patient Fracture Evaluation
Sponsor:
Medtronic Spine LLC
Organization:
Medtronic Spinal and Biologics
Study Overview
Official Title:
A Multicenter Prospective Randomized Controlled Study to Compare Balloon Kyphoplasty to Non-surgical Fracture Management in the Treatment of Painful Acute Vertebral Body Compression Fractures in Cancer Patients
Status:
COMPLETED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAFE
Brief Summary:
The primary objective of this study is to evaluate the safety and effectiveness of balloon kyphoplasty treatment for painful acute vertebral compression fractures VCFs as compared to standard non-surgical therapy in patients with cancer
Detailed Description:
1 STUDY OBJECTIVES AND ENDPOINTS
11 Objectives
The primary objective of this study is to evaluate the safety and effectiveness of balloon kyphoplasty treatment for painful acute VCFs as compared to standard non-surgical therapy in patients with cancer
12 Primary Endpoint
The primary endpoint of the study is the improvement in functional status as measured by the Roland-Morris Disability Questionnaire RDQ at 1 month The primary hypothesis of the study is that the mean improvement will be larger in subjects initially assigned to management with balloon kyphoplasty Note that all subjects will undergo 12 months of follow-up after initial treatment assignment
13 Secondary Endpoints
The following secondary endpoints will also be examined Comparisons will be made at each follow-up visit
Safety
Rate of study treatment-related adverse events
Change in neurological status
Clinical
Change in functional status as assessed with Karnofsky Performance Scale
Change in quality of life as assessed by the SF-36v2 Health Survey
Change in back pain as measured by a 10-point Numerical Rating Scale NRS
Change in back-pain analgesics used
Change in ambulation status
Changes in activities of daily living
Time to treatment failure
Radiographic
Change in spinal deformity defined as the degree of spine angulation as assessed by an independent radiologist at the core laboratory
Rate of subsequent vertebral body fractures as assessed by independent radiologists at the core lab
In each case the study hypothesis is that treatment with balloon kyphoplasty will result in an improvement in clinical or radiographic outcomes compared to baseline and compared to non-surgical treatment with a preservation of outcomes in long-term follow-up
11 Objectives
The primary objective of this study is to evaluate the safety and effectiveness of balloon kyphoplasty treatment for painful acute VCFs as compared to standard non-surgical therapy in patients with cancer
12 Primary Endpoint
The primary endpoint of the study is the improvement in functional status as measured by the Roland-Morris Disability Questionnaire RDQ at 1 month The primary hypothesis of the study is that the mean improvement will be larger in subjects initially assigned to management with balloon kyphoplasty Note that all subjects will undergo 12 months of follow-up after initial treatment assignment
13 Secondary Endpoints
The following secondary endpoints will also be examined Comparisons will be made at each follow-up visit
Safety
Rate of study treatment-related adverse events
Change in neurological status
Clinical
Change in functional status as assessed with Karnofsky Performance Scale
Change in quality of life as assessed by the SF-36v2 Health Survey
Change in back pain as measured by a 10-point Numerical Rating Scale NRS
Change in back-pain analgesics used
Change in ambulation status
Changes in activities of daily living
Time to treatment failure
Radiographic
Change in spinal deformity defined as the degree of spine angulation as assessed by an independent radiologist at the core laboratory
Rate of subsequent vertebral body fractures as assessed by independent radiologists at the core lab
In each case the study hypothesis is that treatment with balloon kyphoplasty will result in an improvement in clinical or radiographic outcomes compared to baseline and compared to non-surgical treatment with a preservation of outcomes in long-term follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None